Cell and Gene Therapy (CGT) Access Model
Provider Frequently Asked Questions (FAQs)
Updated June 27, 2025
The following FAQs provide additional guidance and clarification for Medi-Cal providers regarding the CGT Access Model. As the Department of Health Care Services (DHCS) receives additional questions, this FAQ will be updated. For general information about the CGT Access Model, please refer to the General FAQs.
General
What drugs will be covered under Medi-Cal's CGT Access Model?
Medi-Cal's CGT Access Model will cover the two federal Food and Drug Administration (FDA)-approved CGT medications identified by CMS for treatment of SCD. This includes, CASGEVY™, which is made by Vertex Pharmaceuticals, Inc., and LYFGENIA™, which is made by bluebird bio, Inc.
When can I start billing for CGT SCD medications under Medi-Cal's CGT Access Model?
Enrolled providers may begin providing LYFGENIA to eligible Medi-Cal members for dates of service on or after July 1, 2025, as approved by CMS.
Enrolled providers may begin providing CASGEVY to eligible Medi-Cal members for dates of service on or after September 1, 2025, subject to final CMS approval.
Eligibility
Who is eligible to participate in Medi-Cal's CGT Access Model?
To be eligible for Medi-Cal's CGT Access Model, Medi-Cal members must meet all of the following criteria:
Have a documented medical diagnosis of SCD;
Be actively enrolled in full-scope Medi-Cal at the time the CGT medication is received (note: both Medi-Cal managed care and fee-for-service (FFS) members may be eligible for CGT therapies);
Have Medi-Cal as their primary payer;
Receive one of the two CGT medications from a participating provider; and
Satisfy all published Medi-Cal policy and CGT Access Model requirements.
For more information, please refer to coverage criteria, including prior authorization requirements, which are available online at this website.
Benefits
What benefits am I required to provide under Medi-Cal's CGT Access Model?
Under the CGT Access Model, providers are responsible for providing the following:
Fertility Preservation Services
What benefits am I not required to provide under Medi-Cal's CGT Access Model?
Providers are only required to provide one of the two CGT SCD medications and, if needed, fertility preservation services (as noted above). Aside from this, all other medical and non-medical services are not covered under the CGT Access Model and will be provided and covered depending on the Medi-Cal member's eligibility, as follows:
Medi-Cal FFS: FFS providers must deliver and bill DHCS directly for all other medical and non-medical CGT-related services, including transportation (outside of the cost of the drug, fertility preservation, and qualifying lodging, meals, and travel expenses necessary to receive fertility preservation services as noted above).
Medi-Cal Managed Care: The member's Medi-Cal managed care plan (MCP)is responsible for care coordination and assisting with accessing one of the two CGT sickle cell disease medications. For more information on Medi-Cal MCP care coordination and other requirements, please review the applicable All Plan Letter on DHCS' website. In addition, Medi-Cal MCPs must cover all other medical and non-medical CGT-related services, including transportation (outside of the cost of the drug, fertility preservation, and qualifying lodging, meals, and travel expenses necessary to receive fertility preservation services, as noted above).
How can I connect my patient to services?
If your patient is interested in receiving LYFGENIA, my bluebird support provides Patient Navigators who can help you and your patient explore whether gene therapy is an option, guide your patient through the steps to treatment, and connect them with helpful people and resources along the way. Your patient can complete the Program Enrollment Form directly on their own. Alternatively, you can complete the Program Enrollment Form on a patient's behalf and my bluebird support will reach out to your patient to explain the program and confirm their interest in enrollment. DHCS notes that my bluebird support is available at no cost, and there is no obligation to move forward with CGT SCD treatment.
If you have prescribed CASGEVY to your patient, your patient can enroll in Vertex Connects Patient Support through which they will be assigned a Case Manager who will serve as a resource throughout their CGT journey. Case Managers also help coordinate order placement of CASGEVY, scheduling of apheresis, shipping and logistics, provide updates on the status of the patient's gene therapy during the manufacturing process, and troubleshoot issues. DHCS notes that enrollment in Vertex Connects Patient Support is not required to receive CASGEVY. However, a completed Vertex Connects enrollment form is needed to receive case management services and determine eligibility for certain program offerings. Members will receive a Vertex Connects enrollment form once they are prescribed CASGEVY treatment by their healthcare team.
Billing
How are CGT SCD medications billed?
All claims for CGT medications must be billed directly to DHCS using the appropriate billing code (either J3392 or J3394) and submitted on medical claims using the CMS-1500 (or 837P/I electronic equivalent forms).
Are CGT SCD medications carved out of the managed care delivery system?
Yes, CGT medications for the SCD indication only are carved out of the managed care delivery system, which means Medi-Cal MCPs are not responsible for CGT SCD medication (or fertility preservation costs). This means that providers should not be submitting claims for CGT medication reimbursement to Medi-Cal MCPs. All CGT SCD medication claims must be submitted directly to DHCS that separate out the CGT SCD medication costs from any related, non-medical or medical inpatient hospital stay costs. Providers would then submit one claim for CGT SCD medication reimbursement directly to DHCS and another, separate claim to the applicable Medi-Cal MCP for any related, non-medical or medical inpatient hospital stay costs. However, please note that Medi-Cal MCPs remain contractually and financially responsible for CGT medications for other, FDA-approved, non-SCD indications as well as any related, non-medical or medical costs associated with the CGT medications. This will be further clarified in guidance included within the Medi-Cal Provider Manual and applicable All Plan Letter. Lastly, DHCS will be making necessary system edits to implement this policy. Due to a delay in implementing the necessary system edits, DHCS plans to initiate an Erroneous Payment Process (EPC), which will automatically reprocess and re-adjudicate any inappropriately denied claims.
Are CGT SCD medications carved out of the Diagnosis Related Group (DRG) reimbursement methodology for inpatient hospital stays?
Yes, SCD medications are carved out of the DRG reimbursement methodology for inpatient hospital stays. This means that providers submitting claims for CGT SCD medications must separate out the CGT SCD medication costs from any related, non-medical or medical inpatient hospital stay costs. Providers would then submit one claim for CGT SCD medication reimbursement directly to DHCS and another, separate claim to the applicable Medi-Cal MCP for any related, non-medical or medical inpatient hospital stay costs. DHCS recently released a public notice for State Plan Amendment (SPA) 25-0022. This will be further clarified in guidance included within the Medi-Cal Provider Manual. Lastly, DHCS will be making necessary system edits to implement this policy. Due to a delay in implementing the necessary system edits, DHCS plans to initiate an EPC, which will automatically reprocess and re-adjudicate any inappropriately denied claims.
Center for International Blood and Marrow Transplant (CIBMTR) Research Requirements
What are treatment centers responsible for regarding the CGT Access Model Study?
Treatment centers will be responsible for approaching patients to request their consent to participate in the CIBMTR Research Database Protocol under which this study will be governed and submitting data to CIBMTR, per the CGT Access Model study requirements.
Where can treatment centers find information about the CGT Access Model study?
CIBMTR member centers will receive information about the CGT Access Model study directly from CIBMTR.
Feedback
Where can providers learn more about Medi-Cal's CGT Access Model and/or offer feedback?
Information about Medi-Cal's CGT Access Model is available on DHCS' website, which is available at the following link: Feedback, questions, and comments may also be submitted to DHCS via email at dhcscgt@dhcs.ca.gov.
